FDA.reportPublic FDA data

Australian Gold

Product NDC
13630-0261
11-digit product format
136300261
Labeler code
13630
Product ID
13630-0261_ed86d0bb-9bf2-0cd5-e053-2995a90a45c3
Type
HUMAN OTC DRUG
Nonproprietary name
Avobenzone, Homosalate, Octisalate, Octocrylene
Dosage form
SPRAY
Route
TOPICAL
Labeler
Prime Packaging, Inc.
Application
M020
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2019-10-23
Marketing end
0000-00-00
Substance
AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE
Active strength
25 g/mL; g/mL; g/mL; g/mL
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 223 of 353 · 7,041 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
NAKED SUNDAYS CABANA GLOW MINERAL GLOW SERUM DROPS Blush 40mL SPF 50TITANIUM OXIDE, ZINC OXIDENAKED SUNDAYS PTY LTD0ce809a1-45fb-9d4d-e063-6294a90a26a22025-03-23WarningsExact identifier
application number: M020
GLOW BODY MIST SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENENAKED SUNDAYS PTY LTDcba78484-3c0b-413e-e053-2995a90aad862025-03-23WarningsExact identifier
application number: M020
ISNTREE HYALURONIC ACID NATURAL SUNCREAMZINC OXIDEISNTREE Inc.2a86be75-c0f3-a8a1-e063-6294a90a04482025-03-23WarningsExact identifier
application number: M020
SPF50 SHEER GLOW BALM ESPRESSO MARTINI 9gZINC OXIDE 22.75%NAKED SUNDAY PTY LTDfbfc1e74-139e-8b0d-e053-6394a90a97c52025-03-22WarningsExact identifier
application number: M020
Naked Sundays PoutScreen Plumping Lip Treatment Caramel Latte 10mLLIP TREATMENTNAKED SUNDAYS PTY LTD2499e14a-c14f-ea13-e063-6394a90a62f52025-03-22WarningsExact identifier
application number: M020
Naked Sundays PoutScreen Plumping Lip Treatment Cotton Candy 10mLLIP TREATMENTNAKED SUNDAYS PTY LTD24a7bee2-3802-4786-e063-6294a90a6ab52025-03-22WarningsExact identifier
application number: M020
Naked Sundays PoutScreen Plumping Lip Treatment VANILLA CONFETTI 10mLLIP TREATMENTNAKED SUNDAYS PTY LTD24aa19c8-86d9-c691-e063-6394a90a691e2025-03-22WarningsExact identifier
application number: M020
Naked Sundays PoutScreen Plumping Lip Treatment Marshmallow 10mLLIP TREATMENTNAKED SUNDAYS PTY LTD24a98d3d-f830-9614-e063-6394a90aa7d12025-03-22WarningsExact identifier
application number: M020
SPF50 SHEER GLOW BALM CHAMPAGNE 9gZINC OXIDE 22.75%NAKED SUNDAY PTY LTDfbfb871b-460f-271a-e053-6394a90acad22025-03-22WarningsExact identifier
application number: M020
Naked Sundays Glow Balm Mineral Peptide Stick Broad Spectrum SPF50 Bronze 8gZINC OXIDENAKED SUNDAYS PTY LTD2f42d22a-983e-d304-e063-6294a90a37192025-03-22WarningsExact identifier
application number: M020
SPF50 SHEER GLOW BALM ROSE 9gZINC OXIDE 22.75%NAKED SUNDAY PTY LTDfbfbd0dd-8961-5fd0-e053-6294a90a5de42025-03-22WarningsExact identifier
application number: M020
Naked Sundays Face Body Clear Glow Sunstick SPF50 SHIMMER Broad Spectrum SPF50 19gAVOBENZONE 3%, HOMOSALATE 10%, OCTISALATE 5% ,OCTOCRYLENE 8%NAKED SUNDAYS PTY LTD2f47a6c9-dd0a-da94-e063-6294a90a9a452025-03-22WarningsExact identifier
application number: M020
Obagi Skintrinsiq Firming ProtocolTITANIUM DIOXIDE AND ZINC OXIDEObagi Cosmeceuticals LLC67ba9f32-bbf4-4c14-9e97-08f1cb7d39962025-03-21WarningsExact identifier
application number: M020
Obagi Skintrinsiq Brightening ProtocolHOMOSALATE, OCTISALATE, AND ZINC OXIDEObagi Cosmeceuticals LLC2f75ebf7-d6b6-45c6-ad5b-61739d260ff72025-03-21WarningsExact identifier
application number: M020
Hello Kitty Fun Broad Spectrum SPF 40ZINC OXIDEThe Creme Shop Inc30d37581-122c-ec92-e063-6294a90ab4252025-03-21WarningsExact identifier
application number: M020
Hello Kitty Sunny Days Broad Spectrum SPF 40ZINC OXIDEThe Creme Shop Inc30d3ed8c-f424-8d95-e063-6394a90a0cbc2025-03-21WarningsExact identifier
application number: M020
Carmex Variety Pack Daily Care Moisturizing Lip Balm SPF 15OCTINOXATE, OXYBENZONECarma Laboratories, Inc.c7142781-fa57-43e5-9436-cb29dd03a6692025-03-21WarningsExact identifier
application number: M020
SHISEIDO ULTIMATE SUN PROTECTORAVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENESHISEIDO AMERICAS CORPORATION00ec7d9c-8550-45ce-8d0a-ef2caf84f98d2025-03-21WarningsExact identifier
application number: M020
Obagi Skintrinsiq Clarifiying ProtocolSALICYLIC ACID, TITANIUM DIOXIDE, AND ZINC OXIDEObagi Cosmeceuticals LLC08ba9ea8-73fd-472b-9cc4-67df167352ec2025-03-21WarningsExact identifier
application number: M020
Aveeno Kids Continuous Protection Sensitive Skin Sunscreen Broad Spectrum SPF 50ZINC OXIDEKenvue Brands LLC3e51da46-6a81-4b74-b16e-3fc298a4ba592025-03-20WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
13630-0261-413630026104202 mL in 1 CAN (13630-0261-4) 202 ml2019-10-230000-00-00NoNoCurrent